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Bioethicists from the University of Otago call for a stronger ethical governance system for the editing of human genes as a result of the Chinese experiment to produce children immunized against HIV .
In an opinion piece published in the latest issue of Journal of Zhejian University – SCIENCE B, a major international journal based in China, professors Jing-Bao Nie, Simon Walker and Jing-ru Li of the Center for Bioethics of the Dunedin School of Medicine, in collaboration with Xin-Qing Zhang of Beijing Medical College in China, present their concern aroused by the experience of a Chinese scientist aimed at modifying the genes of human embryos, so that the babies so created are immunized against the immunodeficiency virus human (HIV).
Currently, gene modification techniques are not safe or effective enough to be used on reproductive cell lines, bioethicists said.
"The construction of regulations and laws should be accelerated to respond to the rapid development of emerging biotechnologies.
"The clinical application of human germ-gene editing is in the near future. We invite policymakers to pay special attention to relevant issues, actively address challenges and propose a responsible and achievable pathway." for the clinical translation of the human germline gene editing. "
Although uncertainties remain as to whether the scientist has succeeded in modifying the genes of two babies, bioethicists say that his actions raise a large number of serious ethical problems worldwide, whether they have been proven or not.
These include the questionable scientific and therapeutic benefits of gene editing, an illegitimate ethical badessment procedure, problems related to information and consent processes, as well as others. procedural failures.
The scientist has violated the Chinese and international ethical conventions on the editing of human genes. Although the genome modification technique used (CRISPR-Cas9) is the best gene manipulation technique currently available, Otago's bioethicists claim that its targeting efficiency is still insufficient with other technical problems, including mutations, which could cause defects, disabilities or even cancer.
"A particular problem regarding the editing of germline genes is that unintentional and undesirable changes in germ cells could be transmitted to the offspring, which could lead to unforeseen effects on future generations."
For these reasons, the first International Summit on the Editing of the Human Gene in 2015 recognized that it was irresponsible to proceed with the editing of the genome of the human germline for clinical purposes, a stance that was reaffirmed at the last international summit.
Due to these technical limitations, China has issued several regulations prohibiting the modification of the genome of a human embryo for reproductive purposes, which were ignored by the scientist and the ethics committee with whom he was working .
The scientist claimed to have received ethical approval for the search for a private hospital. However, bioethicists claim that the ethics committee of this hospital was not a registered committee and that its apparent approval is therefore "practically meaningless" from a regulatory point of view.
Although the scientist has obtained agreement from several couples to be included in his study, bioethicists say the process he's used is "highly questionable". The consent form would have been a 23-page document entirely written in English and full of technical words. According to them, it is likely that at least some of the participants would have had difficulty understanding what they were agreeing to. The obligation to pay the fees and the threat of a fine seriously jeopardizes the freedom of the participants to withdraw from the trial and thus constitutes a violation of the principles of the voluntary nature of research with human subjects.
Otago bioethicists say that the rapid development of innovative medical technologies in recent years continues to generate complex ethical problems.
"A public and academic discussion of these challenges and how they should be addressed is absolutely necessary – we can not rely on scientists to address these challenges alone."
Ms. Li is the main author of the article, gathering information while doing fieldwork in China for her doctoral dissertation. She is a PhD Candidate at the Center for Bioethics whose research focuses on the role of the family in informed consent in China.
Explore further:
China: The doctor responsible for genetically modified babies has acted on his own
More information:
Jing-ru LI et al. The experiences that led to the first genetically modified babies: ethical failings and the urgent need for better governance, Journal of Zhejiang University – SCIENCE B (2019). DOI: 10.1631 / jzus.B1800624
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